Study S000832

Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05040971
Acronym: STEP 10
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 207
Start: 2021-09-06
Primary completion: 2023-01-06
Lead sponsor: Novo Nordisk A/S
Conditions: Obesity
Interventions: DRUG:Semaglutide 2.4 mg; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1253-1956; EUDRACT_NUMBER:2020-002939-29

Registered primary outcomes

Change in Body Weight (Percentage [%]) [From randomisation (week 0) to end of treatment (week 52)]
Participants With Change to Normoglycemia [At week 52]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0015817	Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial. McGowan BM, The lancet. Diabetes & endocrinology	2024	Randomized trial	PMID 39089293 DOI	cites ClinicalTrials.gov:NCT05040971; registry reference RESULT:39089293